Nutritive composition for cardiovascular health

ABSTRACT

The present invention relates to the use of nutritional supplement compositions to overcome nutritional deficiencies typically associated with the normal mammalian diet. The compositions of the present invention are obtained by combining fish oil, garlic powder, rutin, capsaicin, vitamin A, vitamin C, vitamin E, selenium, and one or more juice concentrates.

CROSS-REFERENCE TO RELATED APPLICATION

This is a divisional of application Ser. No. 08/845,155 filed on Apr.21, 1997, which is a continuation-in-part of non-provisional applicationSer. No. 08/661,088, filed Jun. 10, 1996 now abandoned. The priority ofthese prior applications are expressly claimed and their disclosure arehereby incorporated by reference in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention provides a novel nutritive compositions, and morespecifically to nutritive compositions containing fish oil, garlic,rutin, capsaicin, vitamin A (beta carotene), vitamin E, vitamin C,selenium and selected juice concentrates, for reducing the levels oftriglycerides, cholesterol, and low density lipoprotein (LDL) in humanblood serum, and for lowering the blood pressure, and for increasing thelevels of high density lipoprotein (HDL) in human blood serum.

2. Background of the Invention

In the last few years, scientific literature has provided strongevidence for a bona fide link between micronutrient compositions (suchas vitamins, minerals, fish oils, and plant extracts) and cardiovasculardisease. For humans of high risk for cardiovascular diseases, realizingan appreciable reduction in the levels of high cholesterol,triglycerides, low density lipoprotein (LDL) in their blood serum isknown to be important for reducing the risk of cardiac diseases. It isalso known that effecting an increase in the levels of high densitylipoprotein (HDL) also provides a significant decrease to the risk ofcardiac diseases.

Cardiovascular disease resulting from the buildup of arterial plaque isknown to be a leading cause of illness and death in humans. Arterialplaque is caused by precipitous material formed chiefly of oxidized lowdensity lipoprotein (O-LDL). The buildup of plaque in the form of O-LDLin the arteries is understood to be a factor in ischemic heart disease.Free radical oxidants, many of which come from naturally occurringsources such as sun exposure, metabolism of certain nutrients, exercise,or are otherwise often observed in persons suffering from diabetes andhigh blood pressure, act to oxidize LDL into its deleterious form,O-LDL. Free radical “scavengers” such as vitamins A, E, C, and seleniumare believed to react with these oxidants and render them, incapable ofoxidation. The inhibitory action of these antioxidants thus inhibits theformation of O-LDL, thereby lowering the levels of arterial plaquedeposits in blood vessels. In contrast, the presence of high densitylipoprotein (HDL) in the body is understood to have beneficial healtheffects. Specifically, HDL is known to be a more soluble form oflipoprotein, hence its presence does not significantly contribute to theformation of arterial plaque. In addition, it is known that HDL is ableto absorb plaque material and may thus directly reduce the amount ofarterial plaque.

3. Description of Prior Art

Essential fatty acids (EFAs) are naturally occurring unsaturated fattyacids with a chain length of 18, 20, or 22 carbon atoms. These EFAscannot be synthesized by the body, hence, dietary intake of EFAs isrequired. Two fatty acids which fall within the family of EFAs areeicosapantaenoic acid (EPA) and docosahexaenoic acid (DFA), both ofwhich are commonly found in fish oils. Epidemiological observationsindicate that fish oils reduce platelet aggregation and serumtriglycerides which may reduce the risk of myocardial infarction,hypertension, atherosclerosis, and certain types of cancer. [Gerster,H., Internat. J. Vit. Nutr. Res., 65:3-20 (1994)]. Specifically, it hasbeen shown that EPA and DHA derived from fish oils play importantstructural roles in membranes of most cells, and influence the fluidityof the cell membranes as expressed by decreased whole-blood viscosityand increased erythrocyte flexibility and deformability [Gerster, citedabove]. In addition, EFAs such as EPA and DHA are known precursors ofeicosanoids—a class of compounds which includes prostanoids such asprostaglandins and thromboxanes, leukotrienes, and hydroxy fatty acids.Eicosanoids are known are known to affect platelet aggregation,permeability and tone of the blood vessel walls, blood pressure, andinflammatory immune reactions. [Gerster, cited above].

Fish oil dietary supplementation is known to have other beneficialhealth effects. Glycogen storage disease is an inherited disorder, andis often complicated by severe hyperlipoproteinemia andhypercholesterolemia, which increase the risk of prematureatherosclerosis and cardiovascular diseases. It has been reported thatpatients suffering from glycogen storage disease that received 10 gramsof fish oil for 3 months experienced a significant decrease in levels oftriglycerides in the blood serum (−49%) and cholesterol levels in theblood serum (−23%), and a reduction in LDL levels in the blood serum(−40%), and a significant increase in HDL levels in the blood serum(+30%). [Levy, E., et al., I. Am. J. Clin. Nutr., 57:922-29 (1993)].

Garlic powder has been proposed to have a number of valuable benefits tothe human body as a preventative against cardiovascular diseases. Forexample, daily ingestion of garlic leads to reduced levels of lipids inhuman blood serum, increased fibrinolysis and tissue plasminogenactivator (t-PA) activity, and decreased plasma fibrogen viscosity, eachof which may lessen the likelihood of cardiovascular disease. [Brosche,T. et al., British J. Clin. Practice, Supp. 69:12-19 (1990); KiesewetterH. et al., British J. Clin. Practice, Supp. 69:24-29 (1990)]. Inaddition, the daily ingestion of garlic is known to reduce the totallevels of cholesterol and, triglycerides in human serum, as well asreduce blood pressure peripheral vasodilation. [Auer, W. et al., BritishJ. Clin. Practice, Supp. 69:3-6 (1990)].

Flavonoids are secondary metabolites which are found in edible plantsand foodstuffs derived from plants. Flavonoids are widely recognized ashaving antiallergic, anti-inflammatory, antiviral, antiproliferative andanticarcinogenic activities. [Manach, C., et al. J. Nutr., 125:1911-22(1995)]. Among flavonoids, flavonols occur most abundantly in plants aspossess most of these biological properties. [Manach, cited above].Flavonols naturally occur as O-glycides, typically having a sugar moietybound at the C-3 position. Rutin is the principal glycoside form ofquercetin, the most abundant flavonol in fruits and vegetables.

Capsaicin is a prominent chemical entity in plants of the Capsicumgenus, which include chili peppers, red pepper, and paprika. Capsaicinis actually a class of compounds of branched- and straight-chain alkylvanillylamides. The antimicrobial and analgesic properties of capsaicinhave been known for centuries. In addition, capsaicin-containingproducts have been used to treat rheumatoid arthritis, osteoarthritis,diabetic neuropathy, postherpetic neuralgia, postmastectomy painsyndrome, cluster headache, and reflex sympathetic syndrome. [Cordell,G. and Araujo, O., Ann. Pharm., 27:330-36 (1993)].

Certain vitamins and minerals, antioxidants, and plant extracts aregenerally known to have beneficial health effects. For example, severalbeneficial aspects of antioxidants have been known for many years.Antioxidants are chemicals that react with free radicals, such ashydroxy radical, to protect certain biological systems. The removal offree radicals from the body has been suggested to increase humanlongevity—specifically, the presence of antioxidants includingsuperoxide dismutase (SOD), carotenoids, alpha-tocopherol, and uric acidis suggested to have a positive correlation with resistance tospontaneous autosidation of tissues and oxidative damage to DNA inmammals (Cutler R., Am. J. Clin. Nutr., 53:373S-9S (1991)). Antioxidantsare a so known to limit destruction of healing brain tissue by freeradicals as shown by the method for resuscitating the brain usingvitamins such as A, E and C or selenium [See, Klatz et al., U.S. Pat. No5,149,321 and PCT application PCT/US92/06681].

In addition to their antioxidant activity, vitamins A, C, and E are wellknown to have other beneficial heath effects. For example, vitamin E isknown to help maintain proper blood sugar levels. As another example,vitamin C is known to play an integral role in the integrity ofconnective and structual tissues in the body. Vitamin A is known to playa role maintaining good vision as well as in growth and development.Hence, an adequate supply or these vitamins is essential in maintainingoptimum health. The use of vitamins A, E, C and selenium has beenproposed as a means to inhibit or prevent collagen cross-linking inhuman skin when used in combination with certain active peptides (See,Geoffrey et al., PCT application WO 90/06102).

Although compositions used to reduce the risks of cardiovascular diseaseare known, the present invention comprises a novel combination of fishoil, garlic, rutin, capsaicin, vitamin A, vitamin C, vitamin E andselenium, and juice concentrates, which achieve this purpose. As such,there remains a reed in the art for novel compositions like those of thepresent invention which may be used to treat or prevent cardiovasculardisease and disorders.

SUMMARY OF THE INVENTION

The present invention relates to the use of nutritional supplementcompositions to overcome nutritional deficiencies typically associatedwith the normal mammalian diet The compositions of the present inventionare obtained by combining fish oil, garlic powder, rutin, capsaicin,vitamin A, vitamin C, vitamin E, selenium, and one or more juiceconcentrates. Specifically, the present invention relates to the dailyadministration of fish oil, garlic powder, rutin, capsaicin, vitamin A,vitamin C, vitamin E, selenium, and one or more juice concentrates, inseparate preparations, or in preparations that contain combinations ofthe ingredients, or preferably, in a single lozenge.

It is therefore an object of the invention to provide nutritious andsafe compositions for human consumption as dietary supplements thatcontain fish oil, garlic powder, rutin, capsaicin, vitamin A, vitamin C,vitamin E, selenium, and juice concentrates.

It is another object to provide novel compositions which will increasethe levels of HDL in human blood serum.

It is a further object of the invention to provide compositions whichwill decrease levels of Q-LDL in human blood serum.

It is still another object of the invention to provide compositionswhich will reduce the levels of cholesterol and triglycerides in humanblood serum.

It is yet another object of the present invention to providecompositions that will lower the blood pressure of the human system.

The increase of HDL and the reduction of cholesterol, triglycerides,blood pressure and O-LDL should act to reduce the risk of heart diseasein humans. Therefore, it is the prime object of the present invention toprovide for the reduction of the risk of cardiovascular disease by dailyadministration of the compositions of the invention.

DETAILED DESCRIPTION OF THE INVENTION

Daily doses of the compositions of the present invention are aimed atreducing the rate of occurrence of heart disease and are comprised of:(1) fish oil; (2) garlic powder; (3) rutin; (4) capsaicin; (5) vitaminA; (6) vitamin C; (7) vitamin E; (8) selenium; and, (9) one or morejuice concentrates.

Throughout the description of the compositions of the present invention,the term “dosage” will refer to a daily dosage—i.e., the total dosageadministered in a single day. A dosage, therefore, may comprise one ormore dosage forms and one or more administrations of such dosage formsin a single day.

The fish oil component of the compositions of the present invention maybe available from commercial sources. [Arista, Pharmachem]. EPA and DHAare the active moieties of the fish oil is component. The fish oilcomponent of the present invention comprises EPA in the amount of about250 mg to about 3500 mg, and most preferably about 3000 mg. Theremainder of the fish oil component comprises from about 150 mg to about2500 mg of DHA, and preferably about 2000 mg of DHA. The total weight ofthe fish oil component of the present invention is from about 500 mg toabout 15,000 mg, and preferably about 5,000 mg to about 10,000 mg perdosage.

The garlic powder used in the compositions of the present invention maybe obtained from commercially available sources. [Extracts, Ashland,Pure-Gar]. In addition, it is preferable to use a deodorized and agedform of garlic powder. A pharmaceutically acceptable form of garlicpowder used in the compositions of the present invention comprises, byweight, from about 100 mg to about 7,000 mg, and more preferably about1,750 mg to about 6,500 mg, and most preferably about 3,500 mg ofdeodorized and aged garlic powder per dosage.

The rutin which is employed in composition s of the present inventionmay also be obtained from commercially available sources. [WestcoChemical, Freeman Industries, Inc.]. The rutin comprises, by weight,from about 10 mg to about 1500 mg, and most preferably about 1000 mg perdosage.

Capsaicin which is used in the compositions of the present inventionsmay be commercially obtained. [AllChem, Good Hope Botanicals]. Thecapsaicin component of the present invention comprises, by weight, fromabout 20 mg to about 1500 mg, and most preferably about 1000 mg ofcapsaicin per dosage.

A compendial grade of vitamin A can be employed as the vitamin Acomponent of the present composition. The vitamin A component comprises,by weight, about 1,000 IU to abort 20,000 IU of vitamin A, preferablyabout 2,000 IU to about 15,000 IU of vitamin A and most preferably about2,500 IU to about 10,000 IU of vitamin A per dose.

A compendial grade of vitamin C can be employed as the vitamin Ccomponent of the present composition. The vitamin C component comprises,by weight, about 50 mg to about 4,000 mg of vitamin C, preferably about150 mg to about 3,000 mg of vitamin C and most preferably about 175 mgto about 2,000 mg of vitamin C per dose.

A compendial grade of vitamin E can also be employed as the vitamin Ecomponent of the present composition. The vitamin E component comprisesabout 50 IU to about 1,000 If vitamin E, preferably about 75 IU to about925 IU of vitamin E, and most preferably about 125 IU to about 425 IU ofvitamin E per dose.

A compendial grade of organoselenium or selenium salt can beincorporated as the selenium component of the present invention.Alternatively, selenium yeast may be used as the source of selenium forthe compositions of the present invention. Such forms of selenium yeastare commercially available. [Universal Foods Corp.]. The seleniumcomponent of the present invention comprises, by weight, about 20 μg toabout 400 μg of selenium, preferably about 55 μg to about 300 μg, andmost preferably about 150 μg to about 250 μg of selenium per dose.

The total weight of the juice concentrates component in the preferredembodiment of the compositions of the present invention is about 1,000mg to about 7,500 mg, and most preferably about 2,000 mg to about 6,000mg per dose.

A suitable composition consistent with the resent invention comprisesjuice concentrates having a concentration of at least 10 times that ofthe native juice in the unconcentrated form, and preferably about 15times more concentrated, and most preferably about 20 times moreconcentrated than the unconcentrated juice. In concentrated form, thejuice concentrates are substantially anhydrous, and are generally inpowder form.

When present, a form of acorn squash concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 1% to about 20% of the weight of the total juiceconcentrate component of the present invention, more preferably about7.5% to about 15%, and most preferably about 8% to about 12% of theweight of the juice concentrate component of the present invention.

When present, a form of alfalfa juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 1% to about 20% of the weight of the total juiceconcentrate component of the present invention, more preferably about7.5% to about 15%, and most preferably about 8% to about 12% of theweight of the juice concentrate component of the present invention.

When present, a form of apple juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 1% to about 20% of the weight of the total juiceconcentrate component of the present invention, more preferably about7.5% to about 15%, and most preferably about 8% to about 12% of theweight of the juice concentrate component of the present invention.

When present, a form of apricot juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 1% to about 20% of the weight of the total juiceconcentrate component of the present invention, more preferably about7.5% to about 15%, and most preferably about 8% to about 12% of theweight of the juice concentrate component of the present invention.

When present, a form of artichoke juice concentrate suitable for use tosupplement the human diet that can be used in present inventioncomprises about 0.5% to about 20% of the weight of the total juiceconcentrate component of the present invention, and most preferablyabout 2% of the weight of the juice concentrate component of the presentinvention.

When present, a form of avocado juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 0.5% to about 20% of the weight of the total juiceconcentrate component of the present invention, and most preferablyabout 1% of the weight of the juice concentrate component of the presentinvention.

When present, a form of banana juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 0.5% to about 20% of the weight of the total juiceconcentrate component of the present invention, and most preferablyabout 1% of the weight of the juice concentrate component of the presentinvention.

When present, a form of bell pepper juice concentrate suitable for useto supplement the human diet that can be used in the present inventioncomprises about 0.5% to about 20% of the weight of the total juiceconcentrate component of the present invention, and most preferablyabout 1% of the weight of the juice concentrate component of the presentinvention.

When present, a form of broccoli juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 1% to about 20% of the weight of the total juiceconcentrate component of the present invention, more preferably about7.5% to about 15%, and most preferably about 8% to about 12% of theweight of the juice concentrate component of the present invention.

When present, a form of brussels sprout juice concentrate suitable foruse to supplement the human diet that can be used in the presentinvention comprises about 1% to about 20% of the weight of the totaljuice concentrate component of the present invention, more preferablyabout 7.5% to about 15%, and most preferably about 8% to about 12% ofthe weight of the juice concentrate component of the present invention.

When present, a form of cabbage juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 1% to about 20% of the weight of the total juiceconcentrate component of the present invention, and most preferablyabout 2% of the weight of the juice concentrate component of the presentinvention.

When present, a form of cantaloupe juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 1% to about 20% of the weight of the total juiceconcentrate component of the present invention, more preferably about7.5% to about 15%, and most preferably about 8% to about 12% of theweight of the juice concentrate component of the present invention.

When present, a form of carrot juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 1% to about 20% of the weight of the total juiceconcentrate component of the present invention, more preferably about7.5% to about 15%, and most preferably about 8% to about 12% of theweight of the juice concentrate component of the present invention.

When present, a form of cauliflower juice concentrate suitable for useto supplement the human diet that can be used in the present inventioncomprises about 1% to about 20% of the weight of the total juiceconcentrate component of the present invention, more preferably about7.5% to about 15%, and most preferably about 8% to about 12% of theweight of the juice concentrate component of the present invention.

When present, a form of celery juice concentrate suitable for use tosupplement the human diet that can be us(ed in the present inventioncomprises about 1% to about 20% of the weight of the total juiceconcentrate component of the present invention, more preferably about7.5% to about 15%, and most preferably about 8% to about 12% of theweight of the juice concentrate component of the present invention.

When present, a form of cherry juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 1% to about 20% of the weight of the total juiceconcentrate component of the present invention, more preferably about7.5% to about 15%, and most preferably about 8% to about 12% of theweight of the juice concentrate component of the present invention.

When present, a form of collard greens juice concentrate suitable foruse to supplement the human diet that can be used in the presentinvention comprises about 1% to about 20% of the weight of the totaljuice concentrate component of the present invention, and mostpreferably about 2% of the weight of the juice concentrate component ofthe present invention.

When present, a form of grape juice concentrate suitable for use tosupplement the human diet that can be use in the present inventioncomprises about 0.5% to about 20% of the weight of the total juiceconcentrate component of the present invention, and most preferablyabout 2% of the weight of the juice concentrate component of the presentinvention.

When present, a form of grapefruit juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 0.5% to about 20% of the weight of the total juiceconcentrate component of the present invention, and most preferablyabout 2% of the weight of the juice concentrate component of the presentinvention.

When present, a form of green barley juice concentrate suitable for useto supplement the human diet that can be used in the present inventioncomprises about 1% to about 20% of the weight of the total juiceconcentrate component of the present invention, more preferably about7.5% to about 15%, and most preferably about 8% to about 12% of theweight of the juice concentrate component of, the present invention.

When present, a form of green leek juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 0.5% to about 2% of the weight of the total juiceconcentrate component of the present invention, and most preferablyabout 2% of the weight of the juice concentrate component of the presentinvention.

When present, a form of green lettuce juice concentrate suitable for useto supplement the human diet that can be used in the present inventioncomprises about 0.5% to about 20% of the weight of the total juiceconcentrate component of the present invention, and most preferablyabout 1% of the weight of the juice concentrate component of the presentinvention.

When present, a form of kale juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 0.5% to about 20% of th weight of the total juiceconcentrate component of the present invention, and most preferablyabout it of the weight of the juice concentrate component of the presentinvention.

When present, a form of kiwi fruit juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 0.5% to about 20% of the weight of the total juiceconcentrate component of the present invention, and most preferablyabout 1% of the weight of the juice concentrate component of the presentinvention.

When present, a form of kohlrabi juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 0.5% to about 20% of the weight of the total juiceconcentrate component of the present invention, and most preferablyabout 1% of the weight of the juice concentrate component of the presentinvention.

When present, a form of leek juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 0.5% to about 20% of the weight of the total juiceconcentrate component of the present invention, and most preferablyabout 1% of the weight of the juice concentrate component of the presentinvention.

When present, a form of lettuce juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 0.5% to about 20% of the weight of the total juiceconcentrate component of the present invention, and most preferablyabout 1% of the weight of the juice concentrate component of the presentinvention.

When present, a form of onion juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 0.5% to about 20% of the weight of the total juiceconcentrate component of the present invention, and most preferablyabout 5% of the weight of the juice concentrate component of the presentinvention.

When present, a form of orange juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 0.5% to about 20% of the weight of the total juiceconcentrate component of the present invention, and most preferablyabout 5% of the weight of the juice concentrate component of the presentinvention.

When present, a form of papaya juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 1% to about 20% of the weight of the total juiceconcentrate component of the present invention, more preferably about7.5% to about 15%, and most preferably about 8% to about 12% of theweight of the juice concentrate component of the present invention.

When present, a form of parsley juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 1% to about 20% of the weight of the total juiceconcentrate component of the present invention, more preferably about7.5% to about 15%, and most preferably about 8% to about 12% of theweight of the juice concentrate component of the present invention.

When present, a form of potato juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 1% to about 20% of the weight of the total juiceconcentrate component of the present invention, more preferably about7.5% to about 15%, and most preferably about 8% to about 12% of theweight of the juice concentrate component of the present invention.

When present, a form of prune Juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 1% to about 20% of the weight of the total juiceconcentrate component of the present invention, more preferably about7.5% to about 15%, and most preferably about 8% to about 12% of theweight of the juice concentrate component of the present invention.

When present, a form of savoy cabbage juice concentrate suitable for useto supplement the human diet that can be used in the present inventioncomprises about 1% to about 20% of the weight of the total juiceconcentrate component of the present invention, more preferably about7.5% to about 15%, and most preferably about 8% to about 12% of theweight of the juice concentrate component of the present invention.

When present, a form of spinach juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 1% to about 20% of the weight of the total juiceconcentrate component of the present invention, more preferably about7.5% to about 15%, and most preferably about 8% to about 12% of theweight of the juice concentrate component of the present invention.

When present, a form of strawberry juice concentrate suitable for use tosupplement the human diet that can be used in the present inventioncomprises about 0.5% to about 20% of the weight of the total juiceconcentrate component of the present invention, and most preferablyabout 2% of the weight of the juice concentrate component of the presentinvention.

When present, a form of sweet potato juice concentrate suitable for useto supplement the human diet that can be used in the present inventioncomprises about 0.5% to a out 20% of the weight of the total juiceconcentrate component of the present invention, and most preferablyabout 2% of the weight of the juice concentrate component of the presentinvention.

When present, a form of swiss chard juice concentrate suitable for useto supplement the human diet that can be used in the present inventioncomprises about 0.5% to about 20% of the weight of the total juiceconcentrate component of the present invention, and most preferablyabout 2% of the weight of the juice concentrate component of the presentinvention.

When present, a form of tomato juice concentrate suitable for, use tosupplement the human diet that can be used in the present inventioncomprises about 1% to about 20% of the weight of the total juiceconcentrate component of the present invention, and most preferablyabout 3% of the weight of the juice concentrate component of the presentinvention.

These preparations may be made by conventional methods. To prepare thecompositions of the invention, the above-described fish oil, garlicpowder, rutin, and capsaicin components are combined in one preparationas the active ingredient in intimate admixture with a suitable carrieraccording to conventional compounding techniques. To prepare thecompositions of the invention, the above-described vitamin A, vitamin E,vitamin C, selenium, and juice concentrate components are combined inone preparation as the active ingredient in intimate admixture with asuitable carrier according to conventional compounding techniques. Thetwo preparations are then co-administered.

Suitable carriers may take a wide variety of forms depending upon theform of preparation desired for administration, e.g., oral, sublingual,nasal, or parenteral.

In preparing the compositions in oral dosage form, any of the usualpharmaceutical media may be employed. For oral liquid preparations(e.g., suspensions, elixirs, and solutions), media containing forexample, water, oils, alcohols, flavoring agents, preservatives,coloring agents and the like may be used. Carriers such as starches,sugars, diluents, granulating agents, lubricants, binders,disintegrating agents, and the like may be used to prepare oral solids(e.g., powders, gel tin capsules, pills, and tablets). Gelatin capsuleare a preferred oral dosage form. Lozenges, and controlled release formsmay also be used. Because of their ease in administration, lozenges,tablets, pills , and capsules represent the most advantageous oraldosage unit form, in which case solid pharmaceutical carriers areobviously employed. If desired, tablets may be sugar coated or enteric,coated by standard techniques.

Examples of these additional inactive components which provide foreasier oral administration include but are not limited to lemonbioflavonoids [Botanical International, Freeman], parsley powder, bee'swax, lecithin, gelatin, purified water, and glycerin. These compoundsmay be used in creating the lozenges of the novel nutritionalsupplements.

For parenteral products, the carrier will usually comprise sterilewater, although other ingredients may be included, e.g., to aidsolubility or for preservation purposes. Injectable suspensions may alsobe prepared, in which case appropriate liquid carriers, suspendingagents, and the like may be employed.

A preferred method for using the present invention is for the user toingest, daily from about 5 to 10 lozenges of the fish oil, garlic,rutin, and capsaicin preparation together with from about 1 to 4lozenges of the vitamin A, vitamin E, vitamin C, selenium, and juiceconcentrate preparation.

The following examples illustrate the preferred embodiments of thepresent invention. These examples are illustrative only, and do notpurport to limit the invention in my fashion.

EXAMPLE 1

The following example provides a preferred composition of the presentinvention. The composition is provided as two separate preparations:lozenge A (fish oil, garlic, capsaicin, and rutin preparation), andlozenge B (vitamin A, vitamin E, vitamin C, selenium, and juiceconcentrate preparation. The proper daily dosage is 5 to 10 of lozenge Aand 1 to 4 of lozenge B.

Ingredient LOZENGE A Weight fish oil* 570 mg garlic powder 194 mg rutin11 mg capsaicin 21 mg lemon bioflavonoids 11 mg parsley powder 38 mgd-alpha tocopherol 5 mg bee's wax 75 mg lecithin 75 mg gelatin 255 mgpurified water 10 mg glycerin 170 mg LOZENGE B Approximate AmountVitamin A (from beta carotene) 2,500 IU Vitamin C 250 mg Vitamin E 50 IUSelenium 50 μg Barley juice concentrate (approx. 20-1) 120 mg Spinachjuice concentrate (approx. 20-1) 125 mg Alfalfa juice concentrate(approx. 20-1) 145 mg Parsley juice concentrate (approx. 20-1) 135 mgArtichoke juice concentrate (approx. 20-1) 135 mg Carrot juiceconcentrate (approx. 20-1) 130 mg Cabbage juice concentrate (approx.20-1) 130 mg Strawberry juice concentrate (approx. 20-1) 130 mg Papayajuice concentrate (approx. 20-1) 130 mg *Fish oil is in the form of300:200 of EPA:DHA.

EXAMPLE 2

Ingredient Approximate Amount Vitamin A (from beta carotene) 2,500 IUVitamin C 250 mg Vitamin E 50 IU Sodium selenate 50 μg Barley juiceconcentrate (approx. 20-1) 140 mg Spinach juice concentrate (approx.20-1) 105 mg Alfalfa juice concentrate (approx. 20-1) 145 mg Parsleyjuice concentrate (approx. 20-1) 105 mg Artichoke juice concentrate(approx. 20-1) 115 mg Carrot juice concentrate (approx. 20-1) 145 mgCabbage juice concentrate (approx. 20-1) 120 mg Strawberry juiceconcentrate (approx. 20-1) 140 mg Papaya juice concentrate (approx.20-1) 130 mg Apple juice concentrate 68 mg glycerin 340 mg fish oil* 980mg garlic powder 350 mg rutin 28 mg capsaicin 22 mg lemon bioflavonoids12 mg parsley powder 31 mg d-alpha tocopherol 5 mg *Fish oil is in theform of 300:200 of EPA:DHA.

EXAMPLE 3

The ingredients of Example 3 are to be combined to form two lozenges.The daily dosage of these lozenges is from 5 to 10 daily.

Ingredient Approximate Amount fish oil* 340 mg garlic powder 144 mgrutin 13 mg capsaicin 22 mg lemon bioflavonoids 12 mg parsley powder 31mg d-alpha tocopherol 5 mg bee's wax 75 mg lecithin 75 mg d-alphatocopheryl acetate 48 mg 700 IU/g [Eastman Chem. Co.] Selenium Yeast(1,000 ppm Se) 27 mg [Universal Foods Corp.] Beta carotene (167,000IU/g) [BASF Corp.] 29 mg Riboflavin [Takeda U.S.A., Inc.] 0.9 mgAscorbic Acid (USP grade) 200 mg [Hoffmann-La Roche, Inc.] Citrus PectinCellulose 6.3 mg [Stauber Performance Ingredients Inc.] MicrocrystallineCellulose [FMC Corp.] 85 mg Di-Calcium phosphate 8.7 mg [Brown ChemicalCo. Inc.] Magnesium Stearate 1.5 mg [Stauber Performance Ingredients,Inc.] Freeze dried alfalfa powder 5.3 mg [Freeze-dry products USA, Inc.]Freeze dried apple powder 6.3 mg [Freeze-dry products USA, Inc.] Freezedried artichoke powder 7.2 mg [Freeze-dry products USA, Inc.] Freezedried onion powder 7.9 mg [Freeze-dry products USA, Inc.] Freeze driedbanana powder 16 mg [Freeze-dry products USA, Inc.] Freeze driedstrawberry powder 17 mg [Freeze-dry products USA, Inc.] Freeze driedcollard greens powder 12 mg [Freeze-dry products USA, Inc.] Freeze driedpapaya powder 13 mg [Freeze-dry products USA, Inc.] Freeze dried greenlettuce powder 19 mg [Freeze-dry products USA, Inc.] Freeze dried tomatopowder 5 mg [Freeze-dry products USA, Inc.] Freeze dried broccoli powder7.9 mg [Freeze-dry products USA, Inc.] Freeze dried cabbage powder 8.2mg [Freeze-dry products USA, Inc.] Freeze dried cantaloupe powder 10.1mg [Freeze-dry products USA, Inc.] Freeze dried cherry powder 7 mg[Freeze-dry products USA, Inc.] Freeze dried kale powder 9 mg[Freeze-dry products USA, Inc.] Freeze dried kiwi fruit powder 8 mg[Freeze-dry products USA, Inc.] Freeze dried kohlrabi powder 7 mg[Freeze-dry products USA, Inc.] Freeze dried grape powder 6 mg[Freeze-dry products USA, Inc.] Freeze dried grapefruit powder 7 mg[Freeze-dry products USA, Inc.] Freeze dried leek powder 8 mg[Freeze-dry products USA, Inc.] Freeze dried brussels sprout powder 7 mg[Freeze-dry products USA, Inc.] Freeze dried orange powder 6 mg[Freeze-dry products USA, Inc.] Freeze dried parsley powder 6 mg[Freeze-dry products USA, Inc.] Freeze dried potato powder 8 mg[Freeze-dry products USA, Inc.] Freeze dried bell pepper powder 5 mg[Freeze-dry products USA, Inc.] Freeze dried prune powder 5 mg[Freeze-dry products USA, Inc.] Freeze dried carrot powder 12 mg[Freeze-dry products USA, Inc.] Freeze dried Swiss chard powder 13 mg[Freeze-dry products USA, Inc.] Freeze dried spinach powder 5 mg[Freeze-dry products USA, Inc.] Freeze dried apricot powder 13 mg[Freeze-dry products USA, Inc.] Freeze dried avocado powder 5 mg[Freeze-dry products USA, Inc.] Freeze dried acorn squash powder 10 mg[Freeze-dry products USA, Inc.] Freeze dried savoy cabbage powder 11 mg[Freeze-dry products USA, Inc.] Freeze dried celery powder 12 mg[Freeze-dry products USA, Inc.] Freeze dried cauliflower powder 15 mg[Freeze-dry products USA, Inc.] Freeze dried sweet potato powder 14 mg[Freeze-dry products USA, Inc.] *Fish oil is in the form of 300:200 ofEPA:DHA.

EXAMPLE 4

The ingredients of Example 4 are to be combined to form 2 lozenges. Thedaily dosage of these lozenges s from 2 to 6 daily.

Ingredient Approximate Amount fish oil* 580 mg garlic powder 184 mgrutin 13 mg capsaicin 22 mg lemon bioflavonoids 12 mg parsley powder 31mg d-alpha tocopherol 5 mg bee's wax 75 mg lecithin 75 mg d-alphatocopheryl acetate 250 mg 700 IU/g [Eastman Chem. Co.] Selenium Yeast(1,000 ppm Se) 130 mg [Universal Foods Corp.] Beta carotene (167,000IU/g) [BASF Corp.] 125 mg Riboflavin [Takeda U.S.A., Inc.] 400 mgAscorbic Acid (USP grade) 600 mg [Hoffmann-La Roche, Inc.] Citrus PectinCellulose 27 mg [Stauber Performance Ingredients Inc.] MicrocrystallineCellulose [FMC Corp.] 190 mg Di-Calcium phosphate 82 mg [Brown ChemicalCo. Inc.] Magnesium Stearate 6.7 mg [Stauber Performance Ingredients,Inc.] Freeze dried alfalfa powder 18 mg [Freeze-dry products USA, Inc.]Freeze dried apple powder 17.2 mg [Freeze-dry products USA, Inc.] Freezedried artichoke powder 16.5 mg [Freeze-dry products USA, Inc.] Freezedried onion powder 19.6 mg [Freeze-dry products USA, Inc.] Freeze driedbanana powder 6.3 mg [Freeze-dry products USA, Inc.] Freeze driedstrawberry powder 14.1 mg [Freeze-dry products USA, Inc.] Freeze driedcollard greens powder 7 mg [Freeze-dry products USA, Inc.] Freeze driedpapaya powder 6 mg [Freeze-dry products USA, Inc.] Freeze dried greenlettuce powder 6 mg [Freeze-dry products USA, Inc.] Freeze dried tomatopowder 6 mg [Freeze-dry products USA, Inc.] Freeze dried broccoli powder6 mg [Freeze-dry products USA, Inc.] Freeze dried cabbage powder 7 mg[Freeze-dry products USA, Inc.] Freeze dried cantaloupe powder 5 mg[Freeze-dry products USA, Inc.] Freeze dried cherry powder 5 mg[Freeze-dry products USA, Inc.] Freeze dried kale powder 10 mg[Freeze-dry products USA, Inc.] Freeze dried kiwi fruit powder 8 mg[Freeze-dry products USA, Inc.] Freeze dried kohlrabi powder 9 mg[Freeze-dry products USA, Inc.] Freeze dried grape powder 15 mg[Freeze-dry products USA, Inc.] Freeze dried grapefruit powder 11 mg[Freeze-dry products USA, Inc.] Freeze dried leek powder 11 mg[Freeze-dry products USA, Inc.] Freeze dried brussels sprout powder 11mg [Freeze-dry products USA, Inc.] Freeze dried orange powder 13 mg[Freeze-dry products USA, Inc.] Freeze dried parsley powder 11 mg[Freeze-dry products USA, Inc.] Freeze dried potato powder 11 mg[Freeze-dry products USA, Inc.] Freeze dried bell pepper powder 12 mg[Freeze-dry products USA, Inc.] Freeze dried prune powder 6 mg[Freeze-dry products USA, Inc.] Freeze dried carrot powder 12 mg[Freeze-dry products USA, Inc.] Freeze dried Swiss chard powder 6 mg[Freeze-dry products USA, Inc.] Freeze dried spinach powder 18 mg[Freeze-dry products USA, Inc.] Freeze dried apricot powder 19 mg[Freeze-dry products USA, Inc.] Freeze dried avocado powder 15 mg[Freeze-dry products USA, Inc.] Freeze dried acorn squash powder 14 mg[Freeze-dry products USA, Inc.] Freeze dried savoy cabbage powder 8 mg[Freeze-dry products USA, Inc.] Freeze dried celery powder 5 mg[Freeze-dry products USA, Inc.] Freeze dried cauliflower powder 6 mg[Freeze-dry products USA, Inc.] Freeze dried sweet potato powder 7 mg[Freeze-dry products USA, Inc.] *Fish oil is in the form of 300:200 ofEPA:DHA.

Many modifications may be made without departing from the basic spiritof the present invention. Accordingly, it will be appreciated by thoseskilled in the art that with in the scope of the appended claims, theinvention may be practiced other than has been specifically describedherein. Hence, the attached claims are intended to cover the inventionembodied in the claims and substantial equivalents thereto.

We claim:
 1. A method of increasing the level of high density lip anddecreasing the levels of oxidized low density lipoprotein andcholesterol in the blood plasma of a human, the method comprising orallyadministering to the human an effective per diem dose of a nutritivecomposition consisting essentially of: a first component consistingessentially of: approximately 500 mg to 15,000 mg fish oil, wherein thefish oil comprises approximately 250 mg to 3500 mg eicosapantaenoic acidand approximately 150 mg to 2500 mg docosahexaenoic acid, approximately100 mg to 7,000 mg garlic powder, approximately 10 mg to 1,500 mg rutin,approximately 20 mg to 1,500 mg capsaicin, and pharmaceuticalexcipients; and a second component consisting essentially of:approximately 1,000 IU to 20,000 IU vitamin A, approximately 50 mg to4,000 mg vitamin C, approximately 50 IU to 1,000 IU vitamin E,approximately 20 μg to 400 μg selenium, and approximately 1,000 mg to7,500 mg of one or more juice concentrates having concentration of atleast 10 times that of the native juice in unconcentrated form, andpharmaceutical excipients.
 2. The method of claim 1 wherein the firstcomponent of the nutritive composition is in the form of one or morelozenges, and the second component of the nutritive composition is inthe form of one or more lozenges, wherein the lozenges are administeredorally to the human to effect the per diem dose.
 3. The method of claim1, wherein the weight ratio of eicosapantaenoic acid to docosahexaenoicacid in the fish oil in the first component of the nutritive compositionis about 3:2.
 4. The method of claim 1, wherein the fish oil of thefirst component of the nutritive composition is present in the amount offrom about 5000 mg to about 10,000 mg per dose.
 5. The method of claim1, wherein the garlic powder in the first component of the nutritivecomposition is present in the amount of from about 1750 mg to about 6500mg per dose.
 6. The method of claim 1, wherein the vitamin A in thesecond component of the nutritive composition is present in the amountof about 2500 IU to about 10,000 IU per dose.
 7. The method of claim 1,wherein the vitamin C in the second component of the nutritivecomposition is present in the amount of about 175 mg to about 2,000 mgper dose.
 8. The method of claim 1, wherein the vitamin E in the secondcomponent of the nutritive composition is present in the amount of about125 IU to about 425 IU per dose.
 9. The method of claim 1, wherein theselenium in the second component of the nutritive composition is presentin the amount of about 150 μg to about it 250 μg per dose.
 10. Themethod of claim 1, wherein the selenium in the second component of thenutritive composition is provided in a form selected from the groupconsisting of an organoselenium chelate, an inorganic selenium salt, anda selenium-enriched yeast.
 11. The method of claim 1, wherein the juiceconcentrates in the second component of the nutritional composition areselected from the group consisting of: acorn squash concentrate, alfalfajuice concentrate, apple juice concentrate, apricot juice concentrate,artichoke juice concentrate, avocado juice concentrate, banana juiceconcentrate bell pepper juice concentrate, broccoli juice concentrate,brussels sprout juice concentrate, cabbage juice concentrate, cantaloupejuice concentrate, carrot juice concentrate, cherry juice concentrate,collard greens juice concentrate grape juice concentrate, grapefruitjuice concentrate, green leek juice concentrate, green barley juiceconcentrate, green lettuce juice concentrate kale juice concentrate,kiwi fruit juice concentrate, kohlrabi juice concentrate, leek juiceconcentrate, lettuce juice concentrate, onion juice concentrate, orangejuice concentrate, papaya juice concentrate, parsley juice concentrate,potato juice concentrate, prune juice concentrate, savoy cabbage juiceconcentrate, spinach juice concentrate, strawberry juice concentrate,sweet potato juice concentrate, swiss chard juice concentrate, andtomato juice concentrate.